| p-Tau217

Phosphorylated Tau-217 protein (p-Tau217) is the most potent plasma biomarker for AD to date. P-tau217 correlates better with CSF and PET measurements of new cortical amyloid-β burden than p-tau181, and more accurately distinguishes AD dementia from non-AD neurodegenerative diseases. The high correlation between p-tau217 and flortaucipir was confirmed in an independent EXPEDITION3 trial cohort. Primary findings were validated using different p-tau217 immunoassays. These findings suggest p-tau217 may be more useful than p-tau181 in the diagnostic workup of AD.
 

| Typical data

As the OD values of the standard curve may vary according to the conditions of the actual assay performance (e.g. operator, pipetting technique, wash technique or temperature effects), the operator should establish a standard curve for each test. Typical standard curve and data are provided below for reference only.

 

Concentration (pg/mL)	50	25	12.5	6.25	3.12	1.56	0.78	0
OD	2.22	1.56	0.92	0.63	0.42	0.25	0.18	0.08
Corrected OD	2.14	1.48	0.84	0.55	0.34	0.17	0.1	-

 

| Repeatability

Intra-assay Precision (Precision within an assay)：CV% < 10%; Inter-assay Precision (Precision between assays)：CV% < 10%
 

| Recovery

The recovery of Rat p-Tau217 spiked at three different levels in samples throughout the range of the assay was evaluated in various matrices.

 

Sample Type	Range(%)	Average Recovery(%)
Serum(n=8)	84-101	96
Plasma(n=8)	92-105	102
Cell Culture Supernates(n=8)	96-109	103

 

| Linearity

Samples were spiked with high concentrations of Rat p-Tau217 and diluted with Universal Diluent to produce samples with values within the range of the assay.

 

		Serum(n=4)	Plasma(n=4)	Cell Culture Supernates(n=4)
1 : 2	Range (%)	84-95	88-95	90-110
	Average (%)	91	92	96
1 : 4	Range (%)	89-103	87-108	105-115
	Average (%)	94	98	108